Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke (AbotMot)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Maryland, Baltimore County
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01072032
First received: February 17, 2010
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Reduced mobility and increased fall risk are significant long-term health problems facing those who have persistent weakness or paralysis in their legs resulting from stroke. Recent innovations in post-stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Because the ankle is so critical in providing forces for normal walking and balance function, impairments at the affected ankle pose a major limitation to achieving optimal rehabilitation outcomes. To address this we have developed a novel ankle robot (Anklebot) to enhance physical therapy for improving walking and balance functions after stroke. It is a computer controlled exercise machine that can be worn during walking or in a seated position for practice with video games. The Anklebot controllers allow for assisting users when they cannot complete a movement, or resisting movement, or simply recording movements and forces.

Passive movement therapy has shown promise in exciting brain to muscle connections for recovery of walking function; however it does not appear to yield optimal results, suggesting that active involvement in task-oriented therapy is essential. Not only is voluntary movement important to initiate this excitation, the brain mechanisms of reward and motivation play an important role. These mechanisms have been widely studied in both humans and animals. Core brain networks involved in reward and motivation are designed to increase a person's involvement with their surroundings, to focus attention and to prompt one to approach reward and avoid punishers. These increases in involvement and the elevated emotions that are part of it have been shown to enhance performance, memory and learning.

The primary purpose of this pilot study is to investigate responses of brain and muscle activity in stroke patients who use the Anklebot during a 3-week / 3-session/week motor learning based training. These responses will be compared to a 3-week delayed entry period in which the participants will perform an at-home walking program equal in time spent to the time they will spend on the Anklebot during the 3-week / 3x/week training. In Addition, after the 3-week delayed entry walking program the subjects will be divided into low and high reward-feedback groups. The low reward-feedback group will receive the Anklebot training with only immediate feedback (they will know if they succeeded on the current trial but they will never know their cumulative score and they will receive minimal social interaction with research team members. While the high-reward feedback group will know their cumulative scores, will receive controlled but abundant social interaction with the research team and will be eligible for prizes of restaurant and movie coupons during individual training sessions and at completion of the study. This will be done to assess the ability of higher reward conditions to increase recovery beyond that of the Anklebot training alone.

To accomplish this subjects with chronic stroke will be divided into the high and low-reward/feedback groups and will then play a series of videogames using the Anklebot, as we noninvasively record brain activity using electroencephalography (EEG) and muscle activity using electromyography (EMG). We will also monitor heart rate using electrocardiograms (ECG). In addition to analyzing brain and muscle information before, during, and after the Anklebot training, we will also assess walking and balance functions immediately before and after the first and last robotic training session and ask the subjects to fill out some standardized questionnaires.


Condition Intervention
Cerebral Stroke
Device: Anklebot (Ankle Robot)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Motor Control [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Walking and Balance Measures [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • EEG Spectral Estimates [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Low-Reward Anklebot training Group
Device: Anklebot (Ankle Robot)
Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery
Active Comparator: Arm 2
High-Reward Anklebot training Group
Device: Anklebot (Ankle Robot)
Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke greater than 3 months prior
  • Residual hemiparetic gait with observable asymmetry in the gait pattern.
  • Women or men aged 21 to 85 years
  • Completed all conventional physical therapy.
  • Adequate language and neurocognitive function to participate in training, testing, and to give informed consent.
  • Minimal ankle flexion in either direction (dorsi- or plantar-)

Exclusion Criteria:

  • MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less)
  • CES-D score > 16
  • Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm.
  • Severe or global receptive aphasia which confounds reliable testing and training.
  • Women of child-bearing potential, if there is any self-reported chance that they may be pregnant.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01072032

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore County
Investigators
Principal Investigator: Ronald N Goodman, PhD VA Maryland Health Care System, Baltimore
  More Information

Additional Information:
No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01072032     History of Changes
Other Study ID Numbers: A7251-W, HP-00043705
Study First Received: February 17, 2010
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
EEG
Robotics (ankle)
Motor-learning
Brain Plasticity

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014